SOCALM
Manufacturer Details
SUN PHARMA
Compositions:
Quetiapine 25mg/100mg/200mg tablets,
|
Strength
|
Rate
|
Packing Style
|
|
25mg
|
17.00
|
10s tablets
|
|
100mg
|
64.67
|
10s tablets
|
|
200mg
|
99.67
|
10s tablets
|
List of Related Indications:
List Of Drugs:
- Quetiapine- Antipsychotic agent -Dibenzepine derivative- (May 2002)
Indication Type Description:
Drug Interaction:
Increased risk of drowsiness and postural hypotension when used with alcohol CYP3A 4 inducers eg phenytoin & carbamazepine may increase plasma levels of quetiapine while CYP3A4 inhibitors eg ketoconazole and erythromycin may increase plasma levels.
Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
79. Quetiapine fumarate SR tablets 21-02-08 For the additional indication
-acute maniac episode assciated with biploar
disorder
US.FDA APPROVED DRUGS DURING 2006
88. Quetiapine SR tablet 200/300mg 01-08-2006 For psychotic disorder
US.FDA APPROVED DRUGS DURING 2007
32. Quetiapine (as fumarate) SR 400mg tablet 05-03-07
(addl.stgth)
As approved
54. Queitiapine SR Tablets 10-04-07
(addl.stgth)
As approved Schizophrenia
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Quetiapine Fumarate Anti-Psychotic 31-05-2002
2.Quetipine Fumarate SR 400mg Tablet 05-03-2007
Addl.stgth
As approved
3.Quetiapine Fumarate SR tablets 21-02-2008
Addl.Indicn
Acute Mania Episode Associated with Bipolar Disorder
4.Quietiapine SR tablets 01-08-2006
200/300mg
For psychotic disorder
5.Quietipine SR 50mg 10-04-2007
Addl.Stgth
As approved
Adverse Reaction:
Headache, asthenia, abdominal pain back pain, fever, chest pain postural and orthostatic hypotension, hypertension, constipation, dry mouth, dyspepsia, diarrhoea leucopenia, elevation in serum transaminase level, weight gain, myalgia, somnolence, dizziness, anxiety rhinitis, rash, dry skin, ear pain, UTI, syncope, neuroleptic malignant syndrome, variations in WBC count neutropenia, eosinophilia, elevation in nonfasting serum TG Level and total cholesterol decrease in thyroid horme levels, prolongation of QTc intervals
Contra-Indications:
Severe CNS depression, bone marrow supression
Special precautions-
CV disease, cerebrovascular disease or conditions that predispose to hypotension
History of seizures, neuroleptic malignant syndrome, tardive dyskinesia
Monitor glycaemic control esp in diabetics
Hepatic or renal impairment Gradual withdrawal is recommended
Monitor for signs of clinical worsening, suicidallity or unusual changes in behaviour
Pregnancy and Lactation
Dosages/ Overdosage Etc:
Date of Approval 2002
Indication
Schizophrenia
Dosage-
Adult- 25mg bid on day
1 increased to 50mg bid on day
2 100mg on day
3 150mg on day
4 Usual dosage range- 300mg - 450mg daily Max - 750mg /day
Elderly - initially 25mg daily increased in steps of 25- 50 mg daily daily according to response
Pregnancy and lactation:
Contraindicated for use during pregnancy and lactation Use with caution
